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WO2011059397A1 - Système de mesure pour un écoulement autonome - Google Patents

Système de mesure pour un écoulement autonome Download PDF

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Publication number
WO2011059397A1
WO2011059397A1 PCT/SE2010/051256 SE2010051256W WO2011059397A1 WO 2011059397 A1 WO2011059397 A1 WO 2011059397A1 SE 2010051256 W SE2010051256 W SE 2010051256W WO 2011059397 A1 WO2011059397 A1 WO 2011059397A1
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WO
WIPO (PCT)
Prior art keywords
probe
membrane
body fluid
fluid
lumen
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/SE2010/051256
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English (en)
Inventor
Anton Karlsson
Henrik FALKÉN
Gabriel ÖSTERDAHL
Jan Liska
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
CMA Microdialysis AB
Original Assignee
CMA Microdialysis AB
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by CMA Microdialysis AB filed Critical CMA Microdialysis AB
Priority to CA2780871A priority Critical patent/CA2780871C/fr
Priority to AU2010318759A priority patent/AU2010318759B2/en
Priority to BR112012011630A priority patent/BR112012011630A2/pt
Priority to US13/509,939 priority patent/US9167997B2/en
Priority to EP10830290.2A priority patent/EP2501286A4/fr
Priority to CN201080061638.6A priority patent/CN102711607B/zh
Publication of WO2011059397A1 publication Critical patent/WO2011059397A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/155—Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/14—Devices for taking samples of blood ; Measuring characteristics of blood in vivo, e.g. gas concentration within the blood, pH-value of blood
    • A61B5/1405—Devices for taking blood samples
    • A61B5/1427—Multiple blood sampling, e.g. at periodic or pre-established intervals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14503—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14525—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using microdialysis
    • A61B5/14528—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using microdialysis invasively
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150015—Source of blood
    • A61B5/15003—Source of blood for venous or arterial blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150274—Manufacture or production processes or steps for blood sampling devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150847—Communication to or from blood sampling device
    • A61B5/15087—Communication to or from blood sampling device short range, e.g. between console and disposable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/153—Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/157—Devices characterised by integrated means for measuring characteristics of blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/41—Detecting, measuring or recording for evaluating the immune or lymphatic systems
    • A61B5/412—Detecting or monitoring sepsis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/686—Permanently implanted devices, e.g. pacemakers, other stimulators, biochips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14542—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue for measuring blood gases
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6867—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive specially adapted to be attached or implanted in a specific body part
    • A61B5/6876—Blood vessel
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00—Metal working
    • Y10T29/49—Method of mechanical manufacture
    • Y10T29/49826—Assembling or joining

Definitions

  • the present invention generally relates to continuous measurement of substances present in body fluid.
  • the present invention can be used when measuring substances that are indicators of pathological conditions and the sampling probe may be placed in a blood vessel.
  • indicator substances include glucose, lactate, pyruvate, glycerol, glutamate, and glutamine, cytokines and heart specific enzymes.
  • Pathological conditions include ischemia, hypoglycemia, hyperglycemia, sepsis, cell membrane damage or lipolysis, vasospasms, metabolic disorders and inflammatory disorders. By measuring indicator substances, pathological conditions may be detected before they lead to clinical signs. It may even be possible to detect processes or conditions that eventually may lead to a pathological condition.
  • blood samples are drawn from a patient before being analysed with a blood gas analyser.
  • a microdialysis probe provided with a semi-permeable membrane is inserted into a vein of a patient.
  • a perfusion fluid (perfusate) is pumped into an inlet lumen before entering a microdialysis chamber on the inside of the membrane.
  • the perfusate absorbs substances in the blood through the membrane and passes into an outlet lumen of the probe and then flows through a sensor where the substances are measured.
  • US-A-5 078 135 describes a measuring system where a drug is administrated to a rat and where a microdialysis probe is placed in the vein of the rat. Mass spectrometry is used to batchwise analyse the dialysate for obtaining pharmacokinetic data.
  • US-A1 -2004/0191848 describes a system for measuring the concentration of glucose in tissue fluid.
  • the system uses a microdialysis probe which is fed with a perfusate already containing glucose.
  • concentration of glucose in the perfusate is controlled using self-adaptive control.
  • the present invention provides a solution for enabling a less complex and more exact system for measuring of substances in a body fluid.
  • analysate is used throughout this description to define an outflow from the probe transported to the sensor and then subsequently analysed.
  • ultrafiltration refers to a membrane filtration in which pressure forces a liquid against a semipermeable membrane. Suspended solids and solutes of high molecular weight are retained, while water and low molecular weight solutes pass through the membrane.
  • probe refers to a catheter or probe suitable to be inserted into a living body.
  • membrane refers to a microporous semipermeable structure.
  • flow lumen refers to a channel inside the probe that actively carries a liquid to and/or from the membrane of a probe.
  • spontaneous flow or spontaneous fluid flow used in the following section means that the flow is generated from the pressurized body fluid entirely without any energized device, such as pumps. In other terms no external or extracorporeal force is used to generate a flow through the membrane and into the flow lumen.
  • the present invention relates to a probe which is adapted to be inserted into a pressurized body fluid and to receive a fluid flow that is subsequently analyzed.
  • the probe comprises an essentially cylindrical elongated body with a proximal part, a distal part and at least one chamber part covered by a membrane, The chamber part is in fluid connection with a flow lumen
  • the probe body is provided with one single flow lumen for transporting a spontaneous flow of fluid, continuously obtained from the body fluid through the membrane, from the chamber to the proximal part of the probe for subsequent measurement of the concentration of one or more substances present in the pressurized body fluid.
  • one single flow lumen means that the probe is devoid of any other flow lumen or comprising one or more inoperable flow lumens, for example conventional flow lumens extending from the chamber part to the proximal part which are plugged.
  • the probe further preferably comprises a through- hole extending from the chamber to the single flow lumen in order to admit passage of fluid flow.
  • the chamber is essentially annular in cross-section and extends laterally along the probe body with a generally cylindrical shape and communicates with single flow lumen with a single through-hole so that fluid communication is established.
  • the membrane is selected with respect to the pressure in the body fluid, so as to accomplish ultrafiltration and thereby generate a spontaneous fluid flow through the membrane and in the lumen of the probe in the range of 1 to 50 ⁇ /min.
  • the pressurized body fluid will have a mean pressure of about 2-250 mmHg.
  • a systolic pressure of about 80-200 mmHg and a diastolic pressure of about 50-120 mmHg, and in the veins the pressure is in the range of 2-8 mmHg.
  • a membrane is selected with suitable liquid permeability, membrane area, thickness, as well as a suitable pore size and surface roughness adapted to face the body fluid.
  • the liquid permeability (Lp) of the membranes applicable with the present invention vary from between about 1 to 150* 10 "4 cm/(bar*s).
  • a suitable liquid permeability is about 5 to 50 *10 "4 cm/(bar*s) in order to obtain a suitable fluid flow rate in the probe from about 2 to 10 ⁇ /min. It lies within the concept of the present invention to select appropriate flow rates in the probe by selecting suitable membrane parameters. On one hand a too low flow rate will generate unacceptable delay times from the pick-up of the flow through the membrane to the moment the carried analytes reach a sensor or a sampling function. On the other hand a too high flow rate may risk causing clinical complications by draining the body site from fluid and generate unnecessary waste.
  • a preferred surface area of membranes with the probe is within the range of 5 to 500 mm , more preferably of about 30 to 200 mm and the membrane has a thickness of 30 to 80 ⁇ .
  • the probes can generally be adapted to be inserted into a blood vessel and have a length of about 5 to 60 cm, while the single flow lumen has an internal diameter of about 0.05 to 0.3 mm, preferably of about 0.15 mm.
  • An especially suitable such probe for insertion into an artery has a membrane with a liquid permeability of 5-50* 10 "4 cm/(bar*s), a membrane area of 30 to 200 mm and a thickness of 30 to 80 ⁇
  • Probes especially suitable for arterial applications include an approximately 50-250 mm long catheter having an external diameter of about 0,7-1.4 mm, an internal flow lumen of about 0,1-0,3 mm, a membrane of a hollow-fibre type with an outer diameter of about 0.9-1.6 mm and a wall thickness of about 30-80 ⁇ , a surface area of about 30-100 mm 2 and a liquid permeability of about 20-50* 10 "4 cm/(bar*s). It is understood that the above values are approximate and may be adapted depending on in which artery the probe is to be placed.
  • a working embodiment of a probe for an arterial application includes an approximately 70 mm long catheter having an external diameter of about 1.1 mm, an internal flow lumen of about 0, 15 mm, a membrane hollow-fibre with an outer diameter of about 1.3 mm and a wall thickness of about 50 ⁇ , a surface area of about 60 mm 2 and a liquid permeability of about 40* 10 "4 cm/(bar*s).
  • the probes can be further adapted for continuous measurement by including sensing functions, or adapted to collect at least one sample for other types of analyze.
  • the probes can also include additional lumens for other conventional purposes than fluid transport, for example admitting direct access (without any membrane) to the pressurized body fluid.
  • the invention in another aspect, relates to a method of manufacturing a probe for insertion into a pressurized body fluid that ascertains a continuous fluid flow through a membrane contacting the body fluid flow lumen extending from a distal to a proximal part of the probe for sampling or sensing of one or more compounds in the body fluid.
  • the method typically comprises the steps of providing an
  • elongated probe body having an internal flow lumen connected to a
  • the chamber coverable with a membrane; estimating the pressure range of the body fluid in a selected body site; selecting a membrane that at the estimated pressure range of body fluid provides a spontaneous fluid flow of about 1-50 ⁇ /min; and finally attaching the membrane to sealingly cover the probe chamber.
  • the membrane is selected in accordance with what have been discussed above regarding consideration to the pressure range of the body fluid with respect to the mentioned important membrane characteristics in order to obtain a desired flow rate in the probe.
  • the elongated probe body can be provided with a single flow
  • the method can involve selecting a membrane from a kit of membranes, wherein each membrane has a liquid
  • the present invention relates to a method for measuring the concentration of one or more substances in a pressurized body fluid with a pressure of about 2 to 250 mmHg. The method
  • a self- flowing system for measuring the concentration of one or more substances or analytes in a pressurized body fluid.
  • the system comprises the above described probe, and a sensor adapted to receive and analyze the fluid.
  • the sensor is connected to the outlet lumen of the probe described above.
  • the sensor continuously provides data to monitoring means.
  • Figure 1 is a basic overview illustrating a scenario where a substance in a pressurised body fluid y is analysed, in accordance with one embodiment.
  • Figure 2 is a block diagram illustrating a system for analysing a substance in a pressurized body fluid, in accordance with another
  • Figure 3 is a schematic part of a cross-sectional view longitudinal through a probe, in accordance with a further embodiment.
  • Figure 4a is a schematic cross-sectional view transverse a probe, according to an example.
  • Figure 4b is a part of a schematic cross-sectional view transverse a probe, in accordance with another embodiment.
  • Figure 5 demonstrates results with a system according to the present
  • a self- flowing measuring system 100 for continuous measurement of substances in a pressurised body fluid will now be described.
  • a measuring probe 102 is inserted into a pressurised body fluid of a patient 104.
  • the pressurised body fluid is the blood flowing in a suitable artery of the patient, e.g. the radial artery.
  • the invention is not limited to measurements of substances in arteries; a skilled person may easily modify the method to be able to perform measurements of substances in any other pressurised body fluid, e.g. any pressurised artery or vein, in the manner described.
  • the pressure of the body fluid will be in the range of 2 to 250 mmHg.
  • the probe 102 is connected to a monitoring means 106, via a sensor 108.
  • the probe 102, the monitoring means 106, and the sensor 108 will be described in more detail in embodiments below.
  • the length of the probe will be 5-60 cm. It should be noted that, even if the above described self- flowing system is adapted to be applied for continuous measurements, a skilled person will easily realise how to modify the system, e.g. to enable collection of samples for analysis in vitro.
  • the self-flowing system 200 comprises a probe 202, a sensor 210, a monitoring means 212, and a waste container 214.
  • the probe 202 is inserted into a suitable container 214.
  • the probe 202 further comprises an outlet lumen 204, one or more through-holes (not shown) connecting the outer surface of the probe 202 with the outlet lumen 204, and an interface 206 covering the through-hole(s).
  • the membrane has a very smooth surface on the part of the membrane being in contact with the body fluid.
  • the sensor 210 is situated adjacent to the proximal end of the outlet lumen 204, and detects the concentration of at least one substance from a pressurised body fluid, when the substance passes from the patient through the membrane via the outlet lumen 204 and into the sensor 210.
  • the invention is not limited thereto; the sensor 210 may alternatively be situated in the outlet lumen 204. According to this
  • the senor 210 is connected to the proximal end of the outlet lumen 204 of the probe 202, and conveys data regarding the detected concentration to the monitoring means 212.
  • monitoring means 212 may be connected wirelessly or by a direct cable. Such monitoring means can be realised as a computer monitor, a display device, etc. Furthermore, the sensor 210 is a flow-through sensor and the fluid flow passing the sensor 210 is collected in the waste container 214. The collection of fluid flow enables further analyses of the fluid flow, e.g.
  • the invention is not limited to the above described embodiments of self- flowing systems 100, 200, a skilled person may easily realise how to modify the self- flowing system 100, 200, e.g. by omitting the waste container 214, by selecting an alternative sensor type and/or another type of monitoring device, etc.
  • the probe 300 comprises a body 302 and a membrane 304.
  • the probe body 302 is partly provided with an outlet lumen 306, and at least one through-hole 308 connecting the outside of the probe body 302 with the outlet lumen 306.
  • the probe body 302 is covered with the membrane304.
  • the semipermeable membrane 304 is selected with special characteristics regarding the liquid permeability Lp, the surface area, as well as -the pores sizes and the surface roughness facing the pressurized body fluid.
  • the membrane is a PAES hollow-fibre membrane from Gambro, with an outer diameter of 1.55 mm and a wall thickness of about 50 ⁇ .
  • the liquid permeability Lp also called hydraulic permeability, hydraulic conductivity or the filtration coefficient (Kf)
  • Kf hydraulic permeability, hydraulic conductivity or the filtration coefficient
  • the surface area of the membrane is about 195 mm 2 .
  • suitable membranes for this application and other applications discussed with the present invention, are found in WO
  • the through-hole 308 is situated at the distal part of the probe body 302.
  • the outlet lumen 306 transports a flow of a liquid comprising substance(s) from a body fluid, which flows through the membrane via the through-hole 308 into the distal end of the outlet lumen 306 and then to the proximal end of the outlet lumen 306.
  • a skilled person realises easily how to manufacture the through-hole 308.
  • a cut is made in the outside of the probe body 302, connecting the outside of the probe body 302 with the outlet lumen 306.
  • the manufacturing of the outlet lumen 306 may, for instance, be performed by forming a longitudinal lumen through the probe body 302 during extrusion, and then providing a stopper (not shown) in the outlet lumen 306 distally from the through-hole 308. The stopper prevents the outlet flow from flowing distally in the outlet lumen 306.
  • the interface 304 will cover just the through-hole(s) 308 of the probe body 302, instead of surrounding the complete probe body 302.
  • a chamber 310 may be created between the interface 304 and the probe body 302.
  • the microdialysis probe 400 comprises a probe body 402, an inlet lumen 404, an outlet lumen 406, a membrane 408, a microdialysis chamber 410, and through-holes 412, 414.
  • the microdialysis probe 400 is adapted to be inserted into a body fluid of a patient, e.g. in an artery or vein.
  • the inlet lumen 404 is provided in the probe body 402 and transports a perfusate to the microdialysis chamber 410 via the through-hole 412, which connects the inlet lumen 404 with the microdialysis chamber 410.
  • the perfusate is pumped into the proximal end of the inlet lumen 404.
  • the perfusate absorbs substances from the body fluid surrounding the microdialysis probe 400, through the membrane 408.
  • the perfusate, which have been absorbing substances, will be denoted as analysate.
  • the through-hole 414 is provided in the probe body 402 and transports the analysate from the microdialysis chamber 410 to the outlet lumen 406, to be transported to the proximal end of the probe 400. Adjacent to the proximal end of the probe 400, a sensor (not shown) may be provided, adapted to analyse the analysate.
  • a self-flowing probe 450 With reference to FIGURE 4b, showing a transversal cross- sectional view, seen from the distal side, a self-flowing probe 450 according to an embodiment will now be described.
  • the self-flowing probe 450 comprises a probe body 452, an outlet lumen 454, a membrane 456, at least one through-hole 460.
  • the self-flowing probe 450 is adapted to be inserted into a pressurised body fluid of a patient, e.g. in a suitable artery or vein.
  • the probe body 452 is covered with the membrane 456, at least where the through-hole is located.
  • the self- flowing probe 452 is adapted to absorb substances and liquid from the surrounding body fluid through the membrane 456, and transport via the through-hole 460 to the outlet lumen 454.
  • the outlet lumen 454 is adapted to further transport the substances and liquid to its proximal, e.g. to be analysed.
  • the analysis may be performed by a flow- through sensor (not shown) at the proximal end of the self-flowing probe 450 and/or by collecting the analysate and analyse it in vitro. How the analysis is performed can easily be realised by a skilled person, and is therefore not necessary to be further discussed here.
  • the self- flowing probe 450 comprises a chamber 458, defining a space between the membrane and the probe body 452.
  • the probe body 452 may further comprise additional components or means for providing
  • an additional lumen 470 to facilitate insertion, measure blood pressure, and draw blood samples may be provided in the probe body 452.
  • An advantage with the self-flowing probe 450 is that no perfusate needs to be supplied to the probe 450. Consequently, no inlet lumen needs to be provided in the self- flowing probe 450, and the design of the self- flowing probe 450 therefore is simplified. Moreover, the probe can be designed with a smaller diameter, or can contain additional components without increasing the diameter of the probe. Additionally, because a system applying the above described self-flowing probe 450 is self-flowing, the system does not need to apply a pump and syringe for supplying perfusate, which makes the system less complex.
  • a comparison test was made with a self-flowing system, described in an embodiment above.
  • a self- flowing probe as described with FIGURE 3 was inserted into a femoral artery of a pig.
  • the diagram comprises two graphs; a first graph indicated by a line illustrates the result of an analysis of glucose performed by applying a flow-through sensor at the proximal end of the self- flowing probe, and analysing the analysate flowing through the sensor.
  • a second graph indicated by black dots illustrates the result of a blood gas analysis of the blood in the femoral artery of the pig.
  • the system will always provide a fluid flow, having the correct concentration of analytes, to the sensor.
  • the liquid and the analytes present in the surrounding body fluid will spontaneously be forced through the membrane.
  • the rate at which the liquid and the analytes will pass depends mostly on the surrounding pressure as well as the liquid permeability and the surface area of the membrane. At a higher pressure as in an artery a lower liquid permeability is suitable. At a lower surrounding pressure as in a vein a higher liquid permeability would be more suitable.
  • a system for continuous measurement of substances in a pressurised body fluid without needing to provide a perfusion fluid to the probe is achieved.
  • the system may be designed without pump, syringe, or perfusion fluid, and will therefore be less complex.
  • the probe may be designed without an inlet channel for perfusion fluid, resulting in that the probe may be designed with smaller dimensions, or contain additional lumens and/or components. Moreover, since no perfusion fluid needs to be provided, the spontaneous fluid flow from the probe to be analysed will not be diluted and will always exactly reflect the concentration in the body fluid.

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  • Investigating Or Analysing Biological Materials (AREA)

Abstract

L'invention concerne un procédé et un dispositif pour mesurer en continu des substances dans un liquide corporel sous pression. Elle concerne également une sonde (202) qui permet de mesurer en continu la teneur d'une ou de plusieurs substances dans un liquide corporel sous pression. La sonde est destinée à être introduite dans le liquide corporel sous pression, et comprend une interface et une lumière de sortie. De plus, la sonde est configurée de manière à établir un écoulement fluidique continu et spontané à partir du liquide corporel par le biais de l'interface vers la lumière de sortie. L'écoulement fluidique provenant de la sortie peut être analysé par un capteur.
PCT/SE2010/051256 2009-11-16 2010-11-16 Système de mesure pour un écoulement autonome Ceased WO2011059397A1 (fr)

Priority Applications (6)

Application Number Priority Date Filing Date Title
CA2780871A CA2780871C (fr) 2009-11-16 2010-11-16 Systeme de mesure pour un ecoulement autonome
AU2010318759A AU2010318759B2 (en) 2009-11-16 2010-11-16 Self-flowing measuring system
BR112012011630A BR112012011630A2 (pt) 2009-11-16 2010-11-16 sistema de medição de auto-circulação
US13/509,939 US9167997B2 (en) 2009-11-16 2010-11-16 Self-flowing measuring system
EP10830290.2A EP2501286A4 (fr) 2009-11-16 2010-11-16 Système de mesure pour un écoulement autonome
CN201080061638.6A CN102711607B (zh) 2009-11-16 2010-11-16 自流测定系统

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US26144909P 2009-11-16 2009-11-16
SE0901453 2009-11-16
SE0901453-1 2009-11-16
US61/261,449 2009-11-16

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WO2011059397A1 true WO2011059397A1 (fr) 2011-05-19

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PCT/SE2010/051256 Ceased WO2011059397A1 (fr) 2009-11-16 2010-11-16 Système de mesure pour un écoulement autonome

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US (1) US9167997B2 (fr)
EP (1) EP2501286A4 (fr)
CN (1) CN102711607B (fr)
AU (1) AU2010318759B2 (fr)
BR (1) BR112012011630A2 (fr)
CA (1) CA2780871C (fr)
WO (1) WO2011059397A1 (fr)

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CN105110281B (zh) * 2015-08-11 2017-11-28 欧先金 一种液体自动摄取并恒温储存的装置和方法
CN107788993A (zh) * 2016-09-06 2018-03-13 陈治宇 一种血液中麻醉药物浓度在线实时监测系统
WO2021239495A1 (fr) * 2020-05-29 2021-12-02 Somnus Scientific Ltd Capteur de propofol

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GB2003388A (en) * 1977-07-29 1979-03-14 Fresenius Kg Device for continuous chemical analysis of fluids
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Also Published As

Publication number Publication date
AU2010318759A1 (en) 2012-06-07
CN102711607B (zh) 2016-05-04
AU2010318759B2 (en) 2014-08-14
EP2501286A1 (fr) 2012-09-26
CA2780871C (fr) 2018-12-11
BR112012011630A2 (pt) 2017-09-19
EP2501286A4 (fr) 2013-09-04
US20120289795A1 (en) 2012-11-15
US9167997B2 (en) 2015-10-27
CN102711607A (zh) 2012-10-03
CA2780871A1 (fr) 2011-05-19

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